MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT

Model Number IPN046734

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the cone of the touhy needle is leaky.

Event Description

It was reported that the cone of the touhy needle is leaky.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needle with no relevant findings.The customer reported the epidural needle was leaking.The customer returned a 10cc lure-lock syringe, one epidural needle w/wings, needle guard and lidstock.A stylet was not returned with the needle.The components were received assembled, reference files inp1900075119.The returned needle was visually examined with and without magnification.Visual examination of the needle revealed that the syringe appears typical with no observed defects or anomalies.However, microscopic examination of the needle revealed the needle's hub is cracked, referenced files anp1900075119.No other defects or anomalies were observed.Functional inspection was performed on the returned needle.A functional leak test was performed per (b)(4) rev.09 req# 7.8 with the leak tester (ref-002902).The returned needle was plugged at the cannula tip with a rubber eraser and the hub of the needle was connected to the leak tester.Pressure was increased to 45psi for 10 seconds (stopwatch c05180).Water was observed leaking/squirting from the hub of the needle where it was cracked, reference (b)(4).A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the needle was leaking was confirmed during the functional inspection.During the functional inspection, water was observed leaking/squirting from the needle's hub.Visual and microscopic inspections revealed the needle's hub had a crack.A device history record review was performed on the epidural needle with no relevant findings.It is unknown how the needle was handled prior to and during use and the pressure used to inject is unknown.Therefore, the potential cause of the needle leaking could not be determined.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9693812
• MDR Text Key: 180325722
• Report Number: 3006425876-2020-00168
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: IPN046734
• Device Catalogue Number: UM-05400-B
• Device Lot Number: 71F19K0232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1